Methods for sampling and relaying patient medical data

ABSTRACT

In an aspect of a method of the present invention, medical data may be obtained either through a wired or wireless connection to a medical device (or both), and may be relayed to a medical data server directly or through an intermediary device (or a combination of both pathways). Accordingly, there is provided a method whereby data from a medical device can be received through one or more of a wired connection and a wireless connection, and a message including the received data for transmission may be formatted for transmission to one or more of: a medical data server and a intermediary device, wherein the intermediary device includes a software program configured to retransmit the message to the medical data server. Data received by the medical server may automatically determine a medical device type based on a medical device identifier. This method can be practiced automatically to allow a medical device for a patient or other subject to be monitored without requiring the patient to manually enter information.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Patent ApplicationSer. No. 60/862,743, filed Oct. 24, 2006; and claims priority to and isa continuation of: U.S. Patent Publication No. 20080097908 filed as U.S.Utility patent application Ser. No. 11/876,689 on 22 Oct. 2007; U.S.Patent Publication No. 20080097909 filed as U.S. Utility patentapplication Ser. No. 11/876,695 on Oct. 22, 2007; U.S. PatentPublication No. 20080097551 filed as U.S. Utility patent applicationSer. No. 11/876,708 on Oct. 22, 2007; U.S. Patent Publication No.20080103554 filed as U.S. Utility patent application Ser. No. 11/876,711on Oct. 22, 2007; U.S. Patent Publication No. 20080103370 filed as U.S.Utility patent application Ser. No. 11/876,713 on Oct. 22, 2007; U.S.Patent Publication No. 20080097910 filed as U.S. Utility patentapplication Ser. No. 11/876,719 on Oct. 22, 2007; U.S. PatentPublication No. 20080215360 filed as U.S. Utility patent applicationSer. No. 11/876,725 on Oct. 22, 2007; U.S. Patent Publication No.20080097911 filed as U.S. Utility patent application Ser. No. 11/876,744on Oct. 22, 2007; U.S. Patent Publication No. 20080097552 filed as U.S.Utility patent application Ser. No. 11/876,732 on Oct. 22, 2007; U.S.Patent Publication No. 20080097917 filed as U.S. Utility patentapplication Ser. No. 11/877,525 on Oct. 23, 2007; U.S. PatentPublication No. 20080103555 filed as U.S. Utility patent applicationSer. No. 11/877,541 on Oct. 23, 2007; U.S. Patent Publication No.20080218376 filed as U.S. Utility patent application Ser. No. 11/877,550on Oct. 23, 2007; U.S. Patent Publication No. 20080224852 filed as U.S.Utility patent application Ser. No. 11/877,582 on Oct. 23, 2007; U.S.Patent Publication No. 20080097550 filed as U.S. Utility patentapplication Ser. No. 11/877,930 on Oct. 24, 2007; U.S. PatentPublication No. 20080183502 filed as U.S. Utility patent applicationSer. No. 11/877,946 on Oct. 24, 2007; U.S. Patent Publication No.20090234672 filed as U.S. Utility patent application Ser. No. 11/877,966on Oct. 24, 2007; U.S. Patent Publication No. 20080097793 filed as U.S.Utility patent application Ser. No. 11/877,994 on Oct. 24, 2007; andU.S. Patent Publication No. 20090112769 filed as U.S. Utility patentapplication Ser. No. 11/923,013 on Oct. 24, 2007; the disclosures ofwhich are incorporated by reference in their entirety for all purposes.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable.

NOTICE OF INCLUDED COPYRIGHTED MATERIAL

A portion of the disclosure of this patent document contains materialwhich is subject to copyright protection. The copyright owner has noobjection to the facsimile reproduction by anyone of the patent documentor the patent disclosure, as it appears in the Patent and TrademarkOffice patent file or records, but otherwise reserves all copyrightrights whatsoever. All trademarks and service marks identified hereinare owned by the applicant.

DESCRIPTION OF THE INVENTION

1. Field of the Invention

The present invention relates to systems and methods for medical datainterchange, and more particularly, to systems and methods formonitoring medical devices through wired connections.

2. Background of the Invention

Historically, patient medical care was often provided for in thepatient's home or some other environment apart from a clinical setting.Physicians, midwives, or other healthcare providers would make housecalls, observe patient symptoms, formulate diagnoses, and providetreatment. As the state of the art of health care evolved over time, thenumber of house calls made by healthcare professionals diminished. Inlarge part, health care providers conducted fewer and fewer house callsbecause it became impractical to bring bulky medical diagnosis and testequipment to the patient. Likewise, it was not cost effective orintellectually feasible for patients to purchase and operate thecomplicated and expensive medical machines in a home setting. Therefore,the health care model changed dramatically, emphasizing patient visitsto health care facilities where an assortment of state-of-the-art testequipment would be available to assist doctors in more accuratelyassessing and treating patients. This meant that patients were nowexpected to come to the doctor, rather than the other way around.

Innovations in electronics in the last twenty years have made availablea large number of more affordable and patient-operable medical devicesthat obviated, at least in part, the need for the patient to go to afacility each time a medical test or device checkup was required. Sizeand expense were not the only factors making this possible; since thenew devices provided sophisticated processing in smaller form factors,the technical complexity required to operate the devices were reduced toa level that would not overwhelm a layperson's knowledge. Unfortunately,although portable medical devices such as blood glucose meters now allowpatients to perform tests outside the context of medical facilities,patients still need to meet with health care providers to discuss theresults obtained.

Some medical devices include ports to allow the communication of data toand from the medical device through a cable or other wired connection.Medical devices that communicate through such wired connections allowhealthcare providers to monitor the operation of the medical device, aswell as to optionally monitor a patient's biological and biometricinformation, the patient's behavior, and other information pertinent tothe treatment of the patient. However, the manner in which medicaldevices communicate data varies depending on the type and manufacturerof the device, and therefore, proprietary equipment has been designed tocommunicate with medical devices only using a specific type of wiredconnection based on the type of medical device being used.

Medical devices can communicate through a wide range of wiredconnections. In the context of this application, “wired connection”generally refers to any physical connection that a medical device cancommunicate through. For example, “wired connections” can also refer toa waveguide, such as an optical fiber. Other wired connections that canbe used by various medical devices include various sizes of tip andsleeve (TS), tip, ring, and sleeve (TRS), and tip, ring, ring, andsleeve (TRRS) connections. Such connections are also commonly referredto as “RCA plugs,” “phone plugs,” and “stereo jacks” and commonlyinclude plug diameters of 2.5 mm and 3.5 mm when used with medicaldevices. Other wired connections, such as serial peripheral interfacebus (SPI) connections, universal serial bus (USB) connections, RS-232serial connections, Firewire (IEEE 1394) and Ethernet connections mayalso be used. A wired connection can also include any solderedelectrical connection, trace on a circuit board, or other physicalconnection. Each of these connections vary not only in the physicalstructure of the connection, but also in the communication protocolsused to transfer data. It would thus be desirable to have the capabilityto communicate with a variety of medical devices regardless of thespecific wired connection they use.

To make patient monitoring more convenient, Remote Patient Monitoring(RPM) was developed. Remote Patient Monitoring (RPM) generally refers tomonitoring one or more conditions of a patient without requiring thepatient to visit a hospital, doctor's office, or other healthcarefacility. RPM can increase the efficiency and effectiveness of providingcare to patients while reducing costs. RPM can be particularly usefulwhen a patient has a long-term or chronic disease that would otherwiserequire frequent visits to a healthcare facility and/or where apatient's treatment regimen should be modified based on changed patientconditions that are monitored by one or more medical devices, such as apacemaker or glucose meter. For example, Type-I Diabetes patients (alifelong condition) use glucose meters to monitor their blood sugarlevel to assist in determining when to take insulin—it would bedesirable if such information could be quickly, easily, and effectivelyrelayed to a heath care provider for review and analysis.

Conventional RPM generally involves the use of a specific monitoringdevice installed in a patient's home. The device collects dataconcerning the patient's condition and relays the data to a healthcareprovider. Some conventional systems require a patient to manually enterthe data. For example, a diabetes patient using a conventional systemfor RPM may be required to sample their blood sugar level using aglucose meter, take note of the reading, and then manually enter thelevel in the conventional system. There are drawbacks with theseconventional devices. Because of their complexity and proprietaryinterfaces, many are very expensive, which reduces the cost-savingsbenefit of RPM. Additionally, they often require a land-line connection(such as phone or VPN) to transmit data and/or are physicallybulky/heavy and therefore difficult to transport. Furthermore,conventional systems are often unable to provide data to healthcareproviders quickly where data must be manually entered by a patient,which can reduce the level of benefit the patient receives from RPM.What is needed, then, is a system to allow health care providers tofreely access patient-related health data, enabling the provider toconduct a virtual house call. What is also needed is a portable deviceand system that interoperates with a variety of medical devicesutilizing a broad range of wired connections to receive medical data,and provides for management and transport of that data to a healthcareprovider.

SUMMARY OF THE INVENTION

Methods and systems according to the present invention may operate inconjunction with any wired connection, including those described above,and may operate in conjunction with multiple wired connections. Inexemplary embodiments, methods and systems according to the presentinvention may be configured to receive medical device data transmittedin any format and from any medical device. One method according to thepresent invention includes receiving data through a wired connectionfrom a medical device, transmitting the data to an intermediary device(such as a properly equipped mobile telephone or personal digitalassistant), and formatting a message including the received data fortransmission to a medical data server. The intermediary device includesa software program configured to receive the data and process it into aformat compatible with the medical data server. In another aspect, amethod according to the present invention includes receiving datathrough a wired connection from a medical device, transmitting the datato an intermediary device (such as a properly equipped mobile telephoneor personal digital assistant), formatting a message including thereceived data for transmission to a medical data server, and receiving acommand from the medical data server.

Another method according to aspects of the present invention includesreceiving data through a wired connection from a medical device,transmitting the data to an intermediary device, formatting a messageincluding the received data for transmission to a medical data server,and transmitting the formatted message from the intermediary device tothe medical data server. Once at the medical data server the informationcan be reviewed by a healthcare professional at a location remote to thepatient. This method may be practiced automatically, either continuouslyor at set intervals, or may be initiated by someone utilizing the system(such as the patient or health care provider). The method preferablyfunctions without the need for the patient to manually enter informationinto a device. This method optionally allows for multiple differentmedical devices used by a single patient to be monitored, even if eachof the devices communicate through different wired connections and/oruse different communication protocols. In another aspect of a method ofthe present invention, medical data may be obtained either through awired or wireless connection (or both), and may be relayed to a medicaldata server directly or through an intermediary device (or a combinationof both pathways). Accordingly there is provided a method whereby datafrom a medical device can be received through one or more of a wiredconnection and a wireless connection, and a message including thereceived data for transmission may be formatted for transmission to oneor more of a medical data server and a intermediary device, wherein theintermediary device includes a software program configured to retransmitthe message to the medical data server.

A method according to another aspect of the present invention includesreceiving data through a wired connection from a medical device by afirst device, storing the data by the first device, transmitting thedata to a second device by the first device, and transmitting the datafrom the second device to a medical data server. The data can be storedfor any desired length of time, and/or until a particular event occurs.For example, the data can be stored until it is verified that the seconddevice and/or the medical data server have received the data, allowingthe data to be retransmitted if necessary. In various embodiments,commands from a medical data server of the present invention can be usedfor the authentication, configuration, and control of the medicaldevice, intermediary device or another device operating in conjunctionwith the present invention, as well as to achieve other purposes.

A method according to another aspect of the present invention includesreceiving data through a wired connection from a medical device,transmitting the data to an intermediary device, formatting a messageincluding the received data for transmission to a medical data server,receiving a command from the medical data server, and encrypting one ormore of the received data, a portion of the received data, and a digestof the received data. The encryption can be implemented usingcombinations of public and private keys, and allows sensitive medicaldata for a patient to be securely transmitted to the intermediary deviceand/or medical data server without being viewed by unintendedrecipients.

One method according to the present invention includes activating afirst device in response to an event, receiving data through a wiredconnection from a medical device by the first device, transmitting thedata to a second device (such as a properly equipped mobile telephone orpersonal digital assistant) by the first device, and transmitting thedata from the second device to a medical data server. Once at themedical data server the information can be reviewed by a healthcareprofessional at a location remote to the patient. This method may bepracticed automatically, either continuously or at set intervals, or maybe initiated by someone utilizing the system (such as the patient orhealth care provider). The method preferably functions without the needfor the patient to manually enter information into a device. This methodallows the first device to be activated only as necessary to communicatewith the medical device in order to conserve battery life.

One method according to the present invention includes receiving datathrough a wired connection from a medical device by a mobile computingdevice, where the wired connection includes an adapter that communicateswith the mobile computing device using a first communication format andthe medical device using a second communication format. The methodfurther includes formatting a message including the received data fortransmission to a medical data server by the mobile computing device.Once at the medical data server the information can be reviewed by ahealthcare professional at a location remote to the patient. This methodmay be practiced automatically, either continuously or at set intervals,or may be initiated by someone utilizing the system (such as the patientor health care provider). The method preferably functions without theneed for the patient to manually enter information into a device. Thismethod optionally allows for multiple different medical devices used bya single patient to be monitored, even if each of the devicescommunicate through different wired connections and/or use differentcommunication protocols. The mobile computing device can be aproperly-equipped cellular telephone, PDA, or other a small, portabledevice that is easy for a patient to transport.

A method according to another aspect of the present invention includesreceiving data through a wired connection from a medical device by amobile computing device, where the wired connection includes an adapterthat communicates with the mobile computing device using a firstcommunication format and the medical device using a second communicationformat. The method further includes formatting a message including thereceived data for transmission to a medical data server by the mobilecomputing device and encrypting one or more of the received data, aportion of the received data, and a digest of the received data. Theencryption can be implemented using combinations of public and privatekeys, and allows sensitive medical data for a patient to be securelytransmitted to the intermediary device and/or medical data serverwithout being viewed by unintended recipients.

A system according to one aspect of the present invention comprises aprocessor, a plurality of device interfaces, a data relay transceiver,and a memory coupled to the processor and storing instructions. Those ofskill in the relevant arts understand that the data relay transceiversreferenced herein may comprise a receiver, a transmitter, or both areceiver and transmitter, and may receive and/or transmit electricalsignals, radio frequency signals, modulated light signals, sonicsignals, or other signals propagated through a suitable medium. Theprocessor executes the instructions in the memory to receive data fromone or more medical devices through a wired connection coupled to atleast one of the device interfaces (which gathers data concerning thepatient's condition), and transmits the data to an intermediary deviceusing the data relay transceiver. This system can be implemented in asmall, portable unit that is easy for a patient to transport. Forexample, the unit could be the size of a cell phone or contained withina cell phone, or could be a small accessory device that is connected tothe medical device, such as in a container in which the medical deviceis also situated. In various embodiments, the user interface of a systemof the present invention may include a microphone and speaker to allowthe communication of audible information between the system and a user.

In another embodiment, a system according to another aspect of thepresent invention comprises a processor, a device interface configuredto receive data from one or more different medical devices, a data relaytransceiver, and a memory coupled to the processor and storinginstructions. The processor executes the instructions in the memory toreceive data from the one or more medical devices through a wiredconnection using the device interface and transmits the data to anintermediary device using the data relay transceiver.

The system can communicate with multiple medical devices, regardless ofthe type of wired connection or communications protocol utilized by eachof the medical devices, and can retransmit (and optionally reformat)data from the medical device(s) to any desired recipient using anysuitable frequency(ies) and communication protocol(s). While certainembodiments operate with radio frequency protocols such as BlueTooth andWiFi, other embodiments may utilize non-rf communications protocols suchas modulated infrared light (e.g. IrDA). Once at the medical data serverthe information can be reviewed by a healthcare professional at alocation remote to the patient.

A system according to another aspect of the present invention comprisesa processor, a plurality of device interfaces, a data relay transceiver,and a memory coupled to the processor and storing instructions. Theprocessor executes the instructions in the memory to receive data fromone or more medical devices through a wired connection coupled to atleast one of the device interfaces, transmits the data to anintermediary device using the data relay transceiver, and encrypts thedata. The data can be encrypted using a combination of public andprivate keys, and allows sensitive medical data for a patient to besecurely transmitted to the intermediary device and/or medical dataserver without being viewed by unintended recipients.

A system according to one aspect of the present invention comprises aprocessor, a device interface, a data relay transceiver, and a memorycoupled to the processor and storing instructions. Those of skill in therelevant arts understand that the data relay transceiver referencedherein may comprise a receiver, a transmitter, or both a receiver andtransmitter, and may receive and/or transmit electrical signals, radiofrequency signals, modulated light signals, sonic signals, or othersignals propagated through a suitable medium. The processor executes theinstructions in the memory to receive data from a medical device througha wired connection using the device interface (which gathers dataconcerning the patient's condition), where the data is received throughan adapter coupled to the device interface and that communicates withthe medical data interchange device using a first communication formatand with the medical device using a second communication format. Theprocessor further executes the instructions in the memory to transmitthe data to an intermediary device using the data relay transceiver.This system can be implemented in a small, portable unit that is easyfor a patient to transport. For example, the unit could be the size of acell phone or contained within a cell phone, or could be a smallaccessory device that is connected to the medical device, such as in acontainer in which the medical device is also situated. As with themethod described above, the system can optionally communicate withmultiple medical devices, regardless of the type of wired connection orcommunications protocol utilized by each of the medical devices, and canretransmit (and optionally reformat) data from the medical device(s) toany desired recipient using any suitable frequency(ies) andcommunication protocol(s). The adapter can be removably coupled to themedical data interchange device to allow different adapters configuredto communicate with different medical devices to be used with a singlemedical data interchange device.

A system according to another aspect of the present invention comprisesa processor, a device interface, a data relay transceiver, and a memorycoupled to the processor and storing instructions. The processorexecutes the instructions in the memory to receive data from a medicaldevice through a wired connection using the device interface where thedata is received through an adapter coupled to the device interface andthat communicates with the medical data interchange device using a firstcommunication format and with the medical device using a secondcommunication format. The processor further executes the instructions inthe memory to encrypt the data and to transmit the data to anintermediary device using the data relay transceiver. The encryption canbe implemented using combinations of public and private keys, and allowssensitive medical data for a patient to be securely transmitted to theintermediary device and/or medical data server without being viewed byunintended recipients.

Embodiments of the present invention may be used to monitor anyappropriate medical device from essentially any location from which acommunications signal can be sent and received. This enables patients toenjoy an active lifestyle by not being tied to medical device monitoringequipment that is difficult or impossible to transport or having toroutinely visit health care facilities. The present invention can beused to monitor any amount and type of data from any medical device.

The present invention can also be used for a variety of other monitoringpurposes. For example, the present invention can be used to monitor ablood alcohol monitor, alcohol breathalyzer, or alcohol ignitioninterlock device to help insure a driver does not operate a motorvehicle under the influence of alcohol or other substance. The presentinvention can also be used in conjunction with a Global PositioningSystem (GPS) or other geolocation device to monitor the position of apatient. The present invention may also be used in a wide variety ofmilitary applications, such as remotely monitoring devices tracking thehealth status of soldiers on a battlefield in real-time in order toquickly dispatch aid to wounded soldiers. The present invention may beused to remotely monitor a chemical, biological agent, or radiationsensor carried by a soldier to detect an attack by unconventionalweaponry.

Embodiments of the medical device of the present invention may transmiton any frequency using any format and protocol. For example, variousmedical devices transmit data in the Wireless Medical Telemetry Service(WMTS) frequency bands. There are three WMTS frequency bands, includingfrequencies from 608 MHz to 614 MHz, 1395 MHz to 1400 MHz, and 1427 MHzto 1432 MHz. In another example, the medical device may transmit usingthe Medical Implant Communications Service (MICS) frequency band,including frequencies from 402 MHz to 405 MHz. In yet another example amedical device may transmit data in the 32 KHz to 175 KHz range.

Both the foregoing summary and the following detailed description areexemplary and explanatory only and are not restrictive of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention may be derived byreferring to the detailed description and claims when considered inconnection with the following illustrative figures.

FIG. 1 is a flow diagram depicting an exemplary process for medical datainterchange according to various aspects of the present invention.

FIG. 2A is a block diagram depicting an exemplary system for medicaldata interchange according to various aspects of the present invention.

FIG. 2B is a block diagram depicting another exemplary system formedical data interchange according to various aspects of the presentinvention.

FIG. 2C is a block diagram depicting yet another exemplary system formedical data interchange according to various aspects of the presentinvention.

FIGS. 3A and 3B depict top and rear views, respectively, of an externalcasing for a medical data interchange device according to variousaspects of the present invention.

FIGS. 3C and 3D depict perspective views of another embodiment of anexternal casing for a medical data interchange device according tovarious aspects of the present invention.

FIG. 3E depicts a perspective view of yet another embodiment of anexternal casing for a medical data interchange device according tovarious aspects of the present invention.

FIG. 4 depicts the interior of an exemplary container for holding amedical device and medical data interchange device according to variousaspects of the present invention.

FIGS. 5A and 5B are a circuit diagrams depicting elements of anexemplary medical data interchange device according to various aspectsof the present invention.

FIG. 6 is a circuit diagram illustrating elements of an exemplaryembodiment of a smart cable with ID and wakeup capability.

FIG. 7 is a circuit diagram illustrating elements of an alternateexemplary embodiment of a smart cable with ID capability.

FIG. 8 is a block diagram depicting a container including light andmotion sensors for activating a medical data interchange device inaccordance with various aspects of the present invention.

FIG. 9 is a flow diagram showing an exemplary process for authenticatingaccess to a system component of the present invention.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

An exemplary method according to an aspect of the present invention isdepicted in FIG. 1. In this method, an identifier is requested from amedical device (105), and data from the medical device is received (110)and validated (115) through a wired connection. An intermediary devicesuch as a mobile phone or personal digital assistant is authenticated(120) and activated (125). The data is transmitted by the medical deviceto the intermediary device (130) and the transmission to theintermediary device is confirmed (135) and validated (140). The data isstored (145) in the intermediate device. A message is formatted (150)and transmitted to a medical data server (155). Optionally, a commandcan be received from the medical data server (160) and optionallyrelayed from the intermediary device. Any combination and/or subset ofthe elements of the method depicted in FIG. 1 may be practiced in anysuitable order and in conjunction with any system, device, and/orprocess. The method shown in FIG. 1 can be implemented in any suitablemanner, such as through software operating on one or more computersystems. Exemplary systems for performing elements of the method shownin FIG. 1 are discussed later in this description.

Request Medical Device ID

In the exemplary process according to aspects of the present inventiondepicted in FIG. 1, an identifier is requested from a medical deviceproviding the data to be monitored (105). Any suitable identifier may beprovided, such as the serial number of the medical device and/or anumeric, alphabetic, alphanumeric, or symbolic identifier. The medicaldevice identifier can be used to determine whether the correct medicaldevice is being monitored. The medical device identifier can also beused to determine the manufacturer, model, type, characteristics, orother information pertinent to the medical device and/or the patient(s)it monitors. The medical device identifier may be received passively,such as from a medical device that automatically includes its identifieras part of its telemetry broadcast. Alternatively, the medical devicecan be polled to request the medical device identifier. The medicaldevice identifier need not be requested from the medical device eachtime the medical device is being monitored. For example, the medicaldevice identifier may be stored in a storage medium for futurereference.

Receive Data from a Medical Device Through a Wired Connection

In the exemplary method shown in FIG. 1, data is received through awired connection from the medical device (110). As stated previously, a“wired connection” in the context of this application refers generallyto any physical connection that allows communication between twodevices. Wired connections thus include, without limitation: tip andsleeve (TS), tip, ring, and sleeve (TRS), and tip, ring, ring, andsleeve (TRRS) connections; serial peripheral interface bus (SPI)connections; universal serial bus (USB) connections; RS-232 serialconnections, Ethernet connections, optical fiber connections, andFirewire connections. Data from a medical device may be received usingany number and combinations of such connections, as well as any othertype of connection. Additionally, medical device may communicate datathrough a wired connection using any suitable format and communicationsprotocol. Alternatively, a plurality of medical devices automaticallytransmitting data on the same frequency, in the same format, andpotentially at the same time (such as in the case of multiple devices ofthe same type and/or from the same manufacturer) can be received inaccordance with the present invention by, for example, using a separatewireless receiver keyed to a unique identifier associated with eachmedical device.

Systems implementing the method depicted in FIG. 1 are preferably small,light, and portable, allowing patients monitored by medical devices tolead active lifestyles without being forced to remain close to anon-portable system receiving the data from the medical device. Data canbe received from any medical device, such as a blood glucose meter, apacemaker, a blood pressure monitor, an insulin pump, a pulse oximeter,a holter monitor, an electrocardiograph, an electroencephalograph, ablood alcohol monitor, an alcohol breathalyzer, an alcohol ignitioninterlock, a respiration monitor, an accelerometer, a skin galvanometer,a thermometer, a patient geolocation device, a scale, an intravenousflow regulator, patient height measuring device, a biochip assay device,a sphygmomanometer, a hazardous chemical agent monitor; an ionizingradiation sensor; a monitor for biological agents, a loop recorder, aspirometer, an event monitor, a prothrombin time (PT) monitor, aninternational normalized ratio (INR) monitor, a tremor sensor, adefibrillator, or any other medical device.

A medical device that includes a combination of different medicaldevices (such as those listed previously) may be monitored in accordancewith the present invention. The medical device can be partially orcompletely implanted in a patient, such as in the case of a pacemaker.Data from the medical device can be received through any number of otherrelay devices, such as routers, hubs, bridges, switches, and modems.Where the medical device is completely implanted in the patient, suchrelay devices can receive data from the medical device wirelessly andretransmit the data through a wired connection. The medical device mayalso be located externally to a patient. The medical device may beconnected to a patient (for example, through one or more electrodes), oroperate independent of any coupling to a patient, such as a scale. Themedical device may also operate in conjunction with a temporaryinterfacing with a patient, such as the case of the cuff of a bloodpressure monitor encompassing the arm of a patient to take a reading.

The medical device data can be received by any person, system, device,or other suitable recipient. The exemplary method in FIG. 1 may bepracticed manually by a human being, automatically by a device, or acombination of the two. Exemplary devices for performing the methodillustrated in FIG. 1 are depicted in FIGS. 2A, 2B, and 2C, and arediscussed in detail below.

Data can be received directly from a medical device. For example, somemedical devices such as glucose meters have ports that allow data to becommunicated through a cable. As mentioned previously, a medical devicecan also provide data using another device, system, or other entity. Inone embodiment of the present invention, for example, a medical deviceprovides data through a serial port (a wired connection) to a computingdevice. The computing device is in turn connected to an Ethernet routeror hub. The data can thus be received through an Ethernet connectionfrom the router or hub. In another exemplary embodiment of the presentinvention, a human patient retrieves data from the medical device andthen provides the data through a keypad, microphone, or other suitableinput device.

The medical device data can be received from a plurality of differentmedical devices, where each medical device may perform any combinationof functions. For example, data from a glucose meter, blood pressuremonitor, and combination scale/height measuring device each transmittingdata in different formats and through different wired connections mayeach be received in accordance with the present invention. In the casewhere a plurality of medical devices transmits data in response to arequest for data, each device in the plurality of devices can be sentsuch a request separately. Alternatively, a plurality of medical devicesautomatically transmitting data in the same format, and potentially atthe same time (such as in the case of multiple devices of the same typeand/or from the same manufacturer) can be received in accordance withthe present invention by, for example, using separate wired connections.When data has been received from a plurality of medical devices, in oneembodiment, a list of the medical devices may be displayed on a userinterface, and optionally, the user may be prompted to select one, all,or none of the plurality medical devices, whose data is desired to betransmitted to the medical data server. The data for the selected set ofmedical devices is then relayed as described with alternate embodimentsas described herein. Any other suitable method for receiving data from aplurality of medical devices may also be used in conjunction with thepresent invention.

Any type of data may be received from a medical device. For example, thedata may include information regarding a patient, such as the patient'sbiological and biometric information, the patient's behaviors, resultsof analysis of physical patient parameters, and information regardingthe patient's environment. For example, a medical device such as aglucose meter could provide data regarding a patient's current (or lastmeasured) blood glucose level, the date and time the patient last usedthe glucose meter, and the current temperature or other environmentalfactors that might affect a glucose test. Other possible environmentalparameters that may be included in the data received from a medicaldevice include a battery charge level, a temperature, a barometricpressure, a code relating to an accessory for the medical device, a datavalidity measurement, an elapsed time since a previous reading by themedical device, a test result parameter, a signal-to-noise parameter,and a quality of service (QoS), and combinations thereof. Data receivedfrom a medical device may also include any other suitable information,such as diagnostic information regarding the medical device.

The medical device data may provide data relating to a single patient ormultiple patients. In the case where a single medical device providesdata regarding multiple patients, the data can be identified with anindividual patient either in the data received by medical device (suchas by using a patient identifier) or through processing in accordancewith the present invention.

The medical device can provide the data in any format. Different medicaldevices from different manufacturers often use different formats forproviding data. For example, data from a glucose meter may be providedin a series of fixed-length data records followed by a terminatorindicator (such as a null or other predefined character) and/or achecksum for validating the data. Any type of data may be provided. Inthe case of a glucose meter, the data may include one or more readingsof a patient's blood glucose level and the date and time each readingwas taken. The medical device identifier discussed previously may beused to determine a specific data format used by a medical device.Alternatively, a data format may be specified by a user or selected byanalyzing the format of the data received and comparing it to a set ofknown medical device data formats.

Validate Data

In the exemplary process shown in FIG. 1, the data from the medicaldevice is validated (115). The data from the medical device can bevalidated in any suitable manner to achieve any result. For example, thedata from the medical device may be validated to ensure it wastransmitted properly and completely. The medical device data may also bevalidated to ensure it was provided from a specific medical device orparticular type of medical device. The data may also be validated toensure that fields in the data correspond to predetermined values and/orare within certain thresholds or tolerances. Any number, code, value oridentifier can be used in conjunction with validating the medical devicedata. For example, the data can be validated by analyzing a medicaldevice serial number, a medical device identifier, a patient identifier,one or more parity bits, a cyclic redundancy checking code, an errorcorrection code, and/or any other suitable feature.

Authenticate/Authorize Intermediary Device

In the exemplary method depicted in FIG. 1, an intermediary devicereceiving the data is authenticated (120). In the context of the presentinvention, the intermediary device includes any type of system or devicecapable of receiving the medical device data in any manner. Suchintermediate devices may include, for example, personal computers,laptops, personal digital assistants, routers, hubs, bridges, switches,modems, and mobile computing devices. The intermediary device mayprocess the data in any manner, and can transmit some or all of the datato another recipient, such as a medical data server. For example, butnot by way of limitation, the intermediary device may include a personalcomputer or a mobile computing device, such as a laptop computer, amobile wireless telephone, or a personal digital assistant (PDA). In anexemplary embodiment of the present invention, the intermediate devicefurther includes software for receiving the medical device data,formatting a message based on the data, and transmitting the formattedmessage to a medical data server. Such software can operate on anysuitable mobile computing device and with any computer operating system.The intermediary device may also include any number of other systems anddevices suitable for receiving data from the medical device, processingthe data, and/or transmitting the data to a medical data server. Furtherdiscussion regarding exemplary embodiments of intermediary devices ispresented later in this description.

The intermediary device can receive the data directly from the medicaldevice, or from one or more other devices. In one exemplary embodimentof the present invention, the intermediary device comprises a mobilecomputing device and is configured to receive data from one or moremedical devices directly through one or more wired connections. Inanother exemplary embodiment of the present invention, the medicaldevice transmits the data to a first device through a wired connection,which in turn transmits the medical device data to the intermediarydevice (wirelessly or through a wired connection).

The intermediary device may be authenticated to achieve any result. Forexample, transmission may be restricted only to authenticated devicesoperating as part of the present invention. Alternatively, For example,the intermediary device may be authenticated to restrict transmission ofthe data from the medical device to intermediary devices operating aspart of the present invention. Authentication can also prevent sensitivemedical data from being broadcast and viewed by unintended recipients.Authentication can also prevent sensitive medical data from beingbroadcast and/or viewed by unintended recipients. The intermediarydevice may also be authenticated to verify the intermediary device isable to receive, process, and/or transmit the medical device data to amedical data server. During authentication, the authenticated device ordevices may also be remotely commanded, and such commands may includesteps that configure devices to interoperate with components of thepresent invention. For example, but not by way of limitation, such stepsmay include the downloading of software applications, applets, embeddedoperating code, and/or data.

The intermediary device can be authenticated in any manner. For example,an intermediary device can be authorized to receive data from one ormore medical devices using an authorization code. The authorization codecan be any number, code, value or identifier to allow the intermediarydevice to be identified as a valid recipient of the data from themedical device. In one exemplary embodiment of the present invention, anintermediary device stores an authorization code and broadcasts theauthorization code in response to a request for authorization. Unlessthe authorization code matches a code stored by the transmitter of themedical device data (such as the medical device itself or anothertransmission device), the medical device data is not transmitted to theintermediary device. Transmission of the medical device data to theintermediary device need not necessarily be predicated upon successfulauthentication of the intermediary device, however. For example, wherethe medical data is related to a medical emergency, the medical datacould be transmitted to any suitable intermediary device within range,whether or not any intermediary device is actually able to beauthenticated or authorized to receive the data.

In another exemplary embodiment of the present invention, anintermediary device receiving the medical device data using a wirelessnetwork protocol (such as Bluetooth) is authenticated based on whetherthe intermediary device advertises one or more services. In thiscontext, advertised services reflect functions, utilities, and processesthe intermediary device is capable of performing. The intermediarydevice broadcasts indicators of this functionality, thus “advertising”them to other systems and devices. In the present exemplary embodimentof the invention, unless the intermediary device advertises a servicethat is identifiable with the operation of the present invention (i.e. aprocess capable of broadcasting the medical device data to a medicaldata server, for example), the intermediary device is not authenticatedand thus the medical device data is not transmitted to the intermediarydevice.

Activate Intermediary Device

In the exemplary process depicted in FIG. 1, the intermediary device canbe activated (125) prior to transmitting the medical device data to theintermediary device. Many devices, particularly mobile computing devicesrunning on batteries, employ power-saving features to conserve batterylife when not in use. In the case where an intermediary device is in apower-saving or standby mode, it may be necessary to activate theintermediary device before it can receive the medical device data. Theintermediary device can be activated in any suitable manner. Forexample, a signal configured to activate the device may be transmittedto prepare the intermediary device to receive the medical device data.

Transmit Data to Intermediary Device

The medical device data is transmitted to the intermediary device (130)in the exemplary process depicted in FIG. 1. The data can be transmittedin any suitable manner. In one exemplary embodiment of the presentinvention, the medical device data is transmitted to the intermediarydevice using a wired connection, such as an RS-232 serial cable, USBconnector, Firewire connector, or other suitable wired connection. Themedical device data can also be transmitted to the intermediary devicewirelessly using a wireless transmitter. Any suitable method of wirelesscommunication can be used to transmit the medical device data, such as aBluetooth connection, infrared radiation, Zigbee protocol, Wibreeprotocol, IEEE 802.15 protocol, IEEE 802.11 protocol, IEEE 802.16protocol, and/or ultra-wideband (UWB) protocol. If desired, the medicaldevice data could be transmitted to the intermediary device using both awired and wireless connection, such as to provide a redundant means ofcommunication, for example.

Any amount of medical device data can be transmitted to the intermediarydevice in any manner. For example, data from the medical device can betransmitted to the intermediary device in real-time as it is measured,or medical device data can be stored (such as in a memory storagedevice) for a period of time before being transmitted to theintermediary device. In some cases, for example, it may be moreefficient to transmit blocks of medical device data at once rather thaninitiating communication with an intermediary device each time data isavailable from the medical device. In other cases, the intermediarydevice may be out of range or otherwise unavailable to receive themedical device data. The medical device data can also be stored for anydesired length of time, and/or until a particular event occurs. Forexample, the medical device data could be stored until it is verifiedthat the intermediary device and/or the medical data server havereceived the data, allowing the data to be retransmitted if necessary.Data can also be deleted when a data record exceeds a predeterminedstorage time, and/or the oldest data record is deleted first after apredetermined storage size limit has been reached.

The medical device data can be transmitted to the intermediary device inany format. For example, the data from the medical device can betransmitted to the intermediary device exactly as it is transmitted fromthe medical device. This would be the case in embodiments of the presentinvention where the medical device itself is transmitting the datadirectly to the intermediary device. Alternatively, in embodiments ofthe present invention where the data is being received from the medicaldevice and then retransmitted to the intermediary device, the medicaldevice data can be reformatted, modified, combined with other data, orprocessed in any other suitable manner before being transmitted to theintermediary device. For example, the medical device data can beencrypted prior to transmission to the intermediary device, and thisencryption may occur at any stage, for instance in the medical deviceitself or at a stage after being transmitted by the medical device. Incases where the medical device data is being combined with other dataand transmitted to the intermediary device, all of the data may beencrypted or simply the medical device data itself. In an alternateembodiment, a digest of the medical data may be encrypted, to digitally“sign” the data contents to verify its authenticity. For example, butnot by way of limitation, this digest may be produced by providing thereceived medical data to a hashing algorithm such as the MD5 or SHA-1Secure Hashing Algorithm as specified in National Institute of Standardsand Technology Federal Information Processing Standard PublicationNumber 180-1.

Asymmetric encryption algorithms and techniques are well known in theart. See, for example, RSA & Public Key Cryptography, by Richard A.Mollin, CRC Press, 2002, and U.S. Pat. No. 4,405,829, issued Sep. 20,1983, the disclosures of which are fully incorporated by referenceherein for all purposes. In an illustrative example, if two parties (forexample, “Alice” and “Bob”) wish to communicate securely using publickey cryptography, each party begins by generating a unique key pair,where one of the keys is a private key that is kept in confidence bythat party, and the other key is a public key that may be publiclydistributed, published only to a message recipient, or made availablethrough a public key infrastructure. The key generation step need bedone by a party only once, provided that the party's private key doesnot become compromised or known by another party. If Alice wants to senda message confidentially to Bob, she may use Bob's public key to encryptthe message, and once sent, only Bob can decrypt and view the messageusing Bob's private key. But if Alice also wanted Bob to have assurancethat the message was in fact coming from her, she could further encryptthe message with her private key before sending, then when Bob's privatekey and Alice's public key are used to decrypt the message, Bob knowsfor certain that he was the intended recipient and that Alice was theone who originated the message, and Alice knows that only Bob will beable to decrypt and read her message.

Asymmetric cryptography may be utilized to enhance security of certainimplementations of the present invention. In an alternate embodiment,data transmitted by a medical device 250 is encrypted with a private keyof the medical device user (or optionally with the private key of ahealth care provider that is operating the medical device), or with apublic key of the intended recipient system such as the medical dataserver 270, or with both keys. The private and/or public keys may bedelivered to the medical data interchange device 200 through a wired orwireless connection, allowing the medical data interchange device 200 tobe configured for secure operation. In one embodiment, the system ormedical data server 270 may request that the public key of the medicaldevice be forwarded to enable decryption of any medical informationencoded with the user's private key. In this manner, the data may beauthenticated as coming from the actual patient that is desired to bemonitored, and optionally, the patient may also be assured that only theintended recipient system or medical device server 270 is capable ofdecrypting and gaining access to the patient's medical device data.

In an alternate embodiment, encrypted or unencrypted data can betransmitted through an encrypted transmission protocol, such as thewireless encryption protocols (WEP, WPA and WPA2) associated with theIEEE 802.11 wireless protocols or a Bluetooth encryption protocolassociated with IEEE 802.15. Any number of other encryption methods canbe used to encrypt the medical device data in conjunction with thepresent invention. The intermediary device may decrypt the medicaldevice data, to allow processing of the data for example. Alternatively,to protect the data from unauthorized viewing, an intermediary devicecould simply retransmit the encrypted data to the medical data server.

Confirm Transmission of Data to Intermediary Device

The transmission of the medical device data can be confirmed (135) toverify the transmission was successful. The transmission can beconfirmed in any suitable manner. For example, the intermediary devicecan transmit an acknowledgement once the transmission is received,otherwise the transmission can be rebroadcast.

Validate Data Transmitted to Intermediary Device

In the exemplary process shown in FIG. 1, the data transmitted to theintermediary device is validated (115). The data from the medical devicecan be validated in any suitable manner to achieve any result. Forexample, the data from the medical device may be validated to ensure itwas transmitted properly and completely. The medical device data mayalso be validated to ensure it was provided from a specific medicaldevice or particular type of medical device. The data may also bevalidated to ensure that fields in the data correspond to predeterminedvalues and/or are within certain thresholds or tolerances. Any number,code, value or identifier can be used in conjunction with validating themedical device data. For example, the data can be validated by analyzinga medical device serial number, a medical device identifier, a patientidentifier, one or more parity bits, a cyclic redundancy checking code,an error correction code, and/or any other suitable feature.

Store Data

The intermediary device may store the medical device data (145). Theintermediary device may store the data in any suitable manner, such asby using a memory storage device. Any portion or amount of medicaldevice data (or other forms of information) received or generated by theintermediary device may be stored for any length of time. The data maybe stored for a predefined period of time and/or until an event occurs.For example, in one embodiment of the present invention the data isstored by the intermediary device until the data has been transmitted tothe medical data server. In another embodiment, data is stored by theintermediary device until a predetermined data transmission record sizehas been reached, so as to reduce communication charges that may accrueduring transmission. In yet another embodiment, the intermediary devicestores the data until an acknowledgment from the medical data server isreceived, where the acknowledgment indicates that the stored data hasbeen received by the medical data server. The medical data may be storedin any desired file format, as well as in an encrypted or decryptedstate.

Format Message for Transmission to Medical Data Server

In the exemplary method according to an aspect of the present inventiondepicted in FIG. 1, a message is formatted for transmission to themedical data server. The message can originate from any entity operatingin conjunction with the present invention. For example, the message maybe created by the intermediary device, a device transmitting the medicaldevice data to the intermediary device, or the medical device itself.The message can include some or all of the medical device data, as wellas any other information useful to the medical data server. Multiplemessages can be formatted to include any desired amount of medicaldevice data. For example, in the case of data from a glucose meter,multiple messages may be formatted to each include a single glucosereading, or a single message could be formatted to include the last tenglucose readings taken by the meter. The message can include any otherdesired data from any suitable source. For example, real-time data froma medical device may be included in a message along withpreviously-transmitted data from the stored by the intermediary devicecreating the message. The message (in whole or in part) may be encryptedto protect the contents of the message from unintended viewers and/orthe privacy of the patient being monitored.

The message provides the medical device information to the medical dataserver in a format the medical data server can recognize and utilize.The message can thus be formatted to only include portions of themedical device data needed by the server and/or additional informationabout a patient, the medical device, and/or the treatment regimen. Themessage can be of any desired format. For example, the message can beincluded in a file having a tokenized format such as standard ASCII textformat, or any other suitable standardized file format, such as an MSWord document, MS Excel file, Adobe PDF file, or binary picture file(JPEG, bitmap, etc.). The data within such a file can be ordered in anymanner and have any suitable delimiters, notations, or other features.For example, a list of multiple glucose level readings in a text filemessage could be provided chronologically by when the readings weretaken, with comma or tab delimiters to denote the start and end of eachreading. The message may also have a unique and/or propriety format.

The format of the message can also be based on the method by which themessage is transmitted to the medical data server. For example, wherethe message is transmitted to the medical data server using a wirelessmobile telephone such as a cellular phone, the message can be formattedas an SMS text message. Similarly, the message may be formatted as anXML record, email, and/or facsimile. The message can include multipleformats and/or multiple messages may be formatted having differentformats for transmission in a variety of methods or to a variety ofrecipient medical data servers.

Transmit Formatted Message to Medical Data Server

The message is transmitted to a medical data server (160) to allow themedical device data to be analyzed and processed. The message can betransmitted to a single medical data server, or to a plurality ofmedical data servers. The medical data server can be any suitablerecipient of the medical device data. For example, the medical dataserver can be a computer system or other device as well as a humanrecipient (such as a doctor, nurse, or other healthcare provider). Themessage may be transmitted to the medical data server by any entityoperating in conjunction with the present invention, and need not be thesame entity that received the medical data or formatted the message. Forexample, the message may be transmitted to the medical data server bythe intermediary device, any device transmitting or receiving themedical device data, or the medical device itself.

The message can be transmitted to the medical data server in anysuitable manner. For example, the message can be transmitted to themedical data server through a wired connection, such as a telephoneline, fiber optic cable, and/or coaxial cable. The message may also betransmitted wirelessly using any suitable wireless system, such as awireless mobile telephony network, General Packet Radio Service (GPRS)network, wireless Local Area Network (WLAN), Global System for MobileCommunications (GSM) network, Enhanced Data rates for GSM Evolution(EDGE) network, Personal Communication Service (PCS) network, AdvancedMobile Phone System (AMPS) network, Code Division Multiple Access (CDMA)network, Wideband CDMA (W-CDMA) network, Time Division-Synchronous CDMA(TD-SCDMA) network, Universal Mobile Telecommunications System (UMTS)network, Time Division Multiple Access (TDMA) network, and/or asatellite communication network. The message may be transmitted usingany suitable combination of multiple wired and wireless communicationmethods. The transmission method selected to transmit the message to themedical data server can be chosen according to any desired criteria. Forexample, one or more transmission methods can be selected from aplurality of possible transmission methods to send the message based oneach method's cost, time required to transmit, reliability, security, orany other suitable factor. Based on such criteria, the message may bestored until there is a suitable opportunity to transmit the message.For example, the message may be stored until an evening or weekend rateis available on a communications network.

Receive a Command from Medical Data Server

In addition to receiving the medical device data, the medical dataserver can transmit a command (160). The command can be received by theintermediary device, the medical device, and/or or any other suitablerecipient. Any number of commands of any type may be transmitted by themedical data server. The command can be transmitted using the samevariety of wired and wireless methods discussed previously for thetransmittal of the formatted message. The command need not betransmitted using the same communication method with which the formattedmessages are transmitted to the medical data server.

In one embodiment of the present invention, for example, the medicaldata server issues a command to reconfigure a software applicationoperating on the intermediary device. In another embodiment, the medicaldata server issues one or more commands to control the functionality ofthe medical device. In yet another embodiment, the medical data serverissues one or more commands to request that a public encryption keycorresponding to the patient using a medical device be forwarded to themedical data server, or that a device associated with the presentinvention receive a public encryption key corresponding to an intendedrecipient such as a particular health care service provider or otherknown destination such as the medical data server. In anotherembodiment, the medical data server issues one or more commands to causethe medical device to perform a warm reset, a cold restart, or to reseta password.

The commands need not be sent directly to a device they are intended tocontrol. For example, a command could be transmitted to an intermediarydevice, which in turn retransmits it (unmodified) to the medical deviceto be controlled. Alternatively, the intermediary device could receive acommand from the medical server, analyze the command, and then transmitan appropriately formatted command tailored to the specific medicaldevice to be controlled. In this manner, the medical data server neednot be able to generate a command for each and every specific device itwishes to control, rather, it can send a command appropriate to a classof devices (i.e. glucose meters) and the intermediary device willappropriately translate the command to control the medical device. Thecommands from the medical data server can initiate/run diagnosticprograms, download data, request the patient's public encryption key,download the intended recipient's public encryption key, and perform anyother suitable function on the intermediary device, medical device, orother devices operating in conjunction with systems and methods of thepresent invention.

In one embodiment, a user of a medical device may interact with themedical data server, and as a result of such interaction, cause acommand to be created by the medical data server and transmitted to themedical device. Such a user may comprise, for example, the patientassociated with the medical device or a health care provider that iscaring for the patient. In various embodiments, the user may interactwith a system that includes the medical data server through a computerinterface (e.g. a web browser), a portable digital assistant (PDA), amobile communication device (such as a cell phone), an emergency medicalbeacon, a medical data interchange device, an interactive voice response(IVR) function associated with the system, or other suitable interface.In one scenario, for example, the user calls the IVR function through acellular network or PSTN connection, and in response to guided voiceprompts, the user either gives vocal input, button-press inputs such asby DTMF tones, or a combination of methods. Based on the user's inputsto the system, whether by IVR or other means, the medical data servermay respond by generating a command that is ultimately transmitted tothe medical device or an intermediary device. In one implementation, themedical data server could generate and transmit a command that instructsthe medical device to transmit data to the medical data server eitherdirectly or through an intermediate device. Such data may represent, forexample, medical or historical information regarding a patient or theuser of the medical device; medical device diagnostic information; orenvironmental parameters such as a battery charge level, a temperature,a barometric pressure, a code relating to an accessory for the medicaldevice, a data validity measurement, an elapsed time since a previousreading by the medical device, a test result parameter, asignal-to-noise parameter, or a quality of service (QoS) parameter. Inone implementation, in response to user input or input associated withanalysis of data uploaded to the medical data server, the medical dataserver causes a command to be transmitted to the medical device thatinstructs the device to take action that results in the administrationof a prescribed dose of medication to the patient, or a prescribed shockto the patient's heart.

A command from a medical data server can be in any appropriate formatand may include any suitable information. For example, a command mayinclude data received from one medical device 250 to be delivered toanother medical device 250 through the medical data interchange device200. In this manner, a variety of medical devices can share data whetheror not they are in communication with the medical data interchangedevice 200.

A command can also originate from an intermediary device 260. Forexample, a command to program or reconfigure one or more softwareprograms on the medical data interchange device 200 depicted in FIGS.2A, 2B, and 2C can be provided by an intermediary device 260 to themedical data interchange device 200 through the data relay transceiver230. A command, as discussed above, may include multiple instructions,applets, or data elements to be processed, such as sections ofexecutable code or interpretable scripts. Additionally, a user canprogram or configure a software program on any device operating inconjunction with the present invention through a suitable userinterface, such as the user interface 290 of medical data interchangedevice 200.

In any system where commands can be sent remotely, security is always aconcern, especially when a wireless implementation may provide an entryvector for an interloper to gain access to components, observeconfidential patient data, and control health-sensitive components suchas pacemakers and insulin pumps. In any digital data network, it is alsopossible that commands intended for one recipient may be misrouted to apatient or health care provider that was not the intended recipient ofthe command. Embodiments of the present invention provide for enhancedsecurity in a remote command system while still allowing flexibility andminimal obtrusiveness.

In one embodiment, a command received by any of the components in FIGS.2A, 2B, or 2C may be authenticated before the command is either actedupon by the destination component, or forwarded to another component inthe system. Authentication may be directed to determining (1) whetherthe command came from a trusted or authorized source and (2) that therecipient is actually the intended recipient of the command. In oneimplementation, source command authentication is achieved by determiningwhether the origin of the command is a trusted component or server, andone way to accomplish this determination is analyzing whether a commandis properly digitally signed by the originator or some otherauthentication information is provided that assures the recipientcomponent that the message or command is authentic and the recipientcomponent is actually the intended recipient. In an alternateimplementation, destination command authentication is accommodated byexamining the contents of the message or an authorization code todetermine the intended recipient, or alternatively decrypting thecommand or a portion of the command to verify the intended recipient.

In one embodiment, when commands are created by a command originator,the originator provides for a means to verify the authenticity and/orvalidity of the command by at least one of the following methods: (1)encrypting the command with a private key of the command originator; (2)generating a digest of the command (through a method such as a hashingalgorithm discussed above) and optionally encrypting the hashed digestwith the command originator's private key, or (3) utilizing a symmetricencryption scheme providing an authentication code (such as acryptographically hashed password) that is compared to previously storedvalues. Then, when a system component receives the command along withany encrypted or cleartext certification data, the component maydetermine the command is valid by (1) attempting to decrypt an encryptedcommand message with the alleged originator's public key, (2) attemptingto decrypt an encrypted digest with the alleged originator's public key,and comparing the result to a hashed value of the command, or (3)comparing a cryptographically hashed password for the alleged originatorto known pre-stored values, and if a match is found, authorization isgranted. As an additional step, if the command were optionally encryptedusing the intended patient/provider's public key, then only therecipient is capable of decrypting the command, ensuring that only thetruly intended patient's health-care devices were being issued commands,and not an unintended third party. For example, in one embodiment,authenticating the command comprises decrypting at least part of thecommand using at least one of: a public key associated with the medicaldata server; a private key associated with a user of the medical device;and a private key associated with the medical device.

Authenticate User Access to Medical Data Server

In another embodiment, in regards to the methods described in regards toFIG. 1, it is desirable to ensure that a party attempting to interfacewith a system such as a medical data server is actually the partybelieved to be authorized to do so. Turning to FIG. 9, an embodiment isprovided that illustrates a method to authenticate user access to themedical data server. A medical data system component 901 such as amedical data server (FIG. 2, 270) generates 910 a request toauthenticate access, either on its own accord or as a result of amessage received by an alleged patient who is enrolled in the medicalservice provided by the medical data server. The medical data system 901then sends a request to authenticate access to a user component 902 ofthe present invention associated with the client, user, or health careprovider, and in one implementation, such component may include themedical data interchange device 200. The user component 902 thenreceives 920 the request to authenticate access, and generates 930 anauthentication token.

In various embodiments, authentication tokens may comprise either simpleor complex text strings or data values indicating an account number orother patient identifier that can be matched against an internal patientdatabase by the medical data server. Alternatively, authenticationtokens may comprise encoded passwords or other indicia that assert thatthe entity for whom authentication is requested is genuine. Generationof an authentication token may be accomplished using alternative methodssuch as entry of a patient identifier, PIN, or password by a patient orhealthcare provider after being prompted to do so. Alternatively, abiometric measurement of the patient or healthcare provider could beobtained and the measurement rendered into a digital representation.Once generated, for security purposes the authorization token may besecured 940 by encrypting the token, digesting and encrypting the digestof the token, or cryptographically hashing the token before transmissionto the requesting entity such as the medical data system 901 or server.As discussed above in regards to the abovementioned commandauthentication, in one embodiment, when authentication tokens arecreated, the originating component of the token may create acertification of validity through at least one of the following methods:(1) encrypting the token with a private key associated with the tokenoriginator; (2) encrypting the token with a public key associated withthe token requester or destination; (3) generating a digest of the token(through a method such as a hashing algorithm discussed above) andoptionally encrypting the hashed digest with the token originator'sprivate key, or (4) providing an authentication code as at least part ofthe token (such as a cryptographically hashed password) that may be iscompared to previously stored values. Then, when a medical data systemcomponent 901 receives the token along with any encrypted or cleartextcertification data, the component may determine the access is valid by(1) attempting to decrypt an encrypted token with the allegedoriginator's public key; (2) attempting to decrypt an encrypted tokenwith the alleged originator's public key; (3) attempting to decrypt anencrypted digest with the alleged originator's public key, and comparingthe result to a hashed value of the token, pin, code, or password, or(4) comparing a cryptographically hashed password for the allegedoriginator to known pre-stored values, and if a match is found,authorization is granted.

The medical data system component 901 then receives 960 and analyzes 970the validity of the authentication token as described above. Ifexamination of the authentication token provides that the token isauthentic, such as by comparing the analyzed token data to known,pre-stored values such as the patient or the patient's health careprovider's pre-stored hashed password or other identity datum, thenaccess is successful and the process terminates. After analyzing theauthentication token or a message containing or associated with thetoken, the medical data system may determine that access is eitherpermitted or denied, and may communicate 980 this status to theoriginator of the authentication token 902 who then receives notice ofthe failure 990. At that point, the system may repeat the process 900,allowing the token originator to attempt access again.

Exemplary Systems

Exemplary systems for use in conjunction with the present invention aredepicted in FIGS. 2A, 2B, and 2C. These systems may be used inconjunction with the method described in FIG. 1, as well as with anysubset or combination of the elements thereof. The systems shown inFIGS. 2A, 2B, and 2C may also be used in conjunction with any othersuitable embodiments of systems and methods for medical devicemonitoring according to an aspect of the present invention.

The exemplary system depicted in FIG. 2A is a medical data interchangedevice 200 that includes a processor 210 coupled to a memory 220. A datarelay transceiver 230 wirelessly communicates with one or moreintermediary devices 260 via antenna 232, which in turn communicateswith one or more medical device servers 270 through either a wired orwireless protocol. An external adapter module 240 communicates with oneor more medical devices 250. The adapter module 240 also communicateswith a device interface 242, as can any number of external devices, suchas a computer system 280. The device interface 242 may include anynumber of wired or wireless connections such as a universal serial bus(USB) connection, serial connection, parallel connection, Firewireconnection (such as IEEE 1394), Ethernet connection, or any othersuitable connection. Those of skill in the relevant arts also recognizethat computer system 280 may also comprise external storage media suchas a FLASH drive or a portable hard drive. The exemplary system shown inFIG. 2B includes a modular adapter 240 removably attached to the medicaldata interchange device 200. In one implementation of this embodiment,the device interface 242 is integrated with the adapter module 240.

The medical data interchange device 200 may include any suitable powerconnection for powering the interchange device and/or for recharging anenergy storage device such as a battery (not shown). The components ofthe medical data interchange device 200 may receive electrical powerfrom any other type of power supply.

The device interface 242 may establish unidirectional or bidirectionalcommunications with one or more of the medical devices 250 through theadapter 240. The adapter 240 may be located internally or externally tothe device interface 242 and/or medical data interchange device 200. InFIG. 2A, for example, the device interface 242 connects to an adapter240 that is external to the medical interchange device 200, while FIG.2B depicts the device interface 242 being integrated with the adapter240.

FIG. 2C depicts an exemplary embodiment of the present invention whereinthe medical data interchange device 200 is integrated with a medicaldevice 250. The medical data interchange device 200 can be integratedwith the medical device 250 using any number of suitable wiredconnections (i.e.—soldered connections and/or traces on a printedcircuit board) to allow the medical data interchange device 200 tocommunicate with components in the medical device 250. As with themedical data interchange devices 200 depicted in FIGS. 2A and 2B, themedical data interchange device 200 depicted in FIG. 2C can communicatewith any number of intermediary devices 260 and/or medical data servers270.

The functionality of the medical data interchange device 200 can beimplemented in any suitable manner, such as through the processor 210executing software instructions stored in the memory 220. Functionalitymay also be implemented through various hardware components storingmachine-readable instructions, such as application-specific integratedcircuits (ASICs), field-programmable gate arrays (FPGAs) and/or complexprogrammable logic devices (CPLDs). Systems for medical data interchangeaccording to an aspect of the present invention may operate inconjunction with any desired combination of software and/or hardwarecomponents.

Medical Data Interchange Device 200

Referring to FIGS. 3A and 3B, the medical data interchange device 200depicted in FIGS. 2A and 2B is shown enclosed within a within a case300. A case holding a system for medical data interchange according toaspects of the present invention may be of any size, shape andconfiguration. The system (and case enclosing it) is preferably smallenough to be easily portable by a patient or person being monitored. Forexample, the exemplary case 300 depicted in FIGS. 3A and 3B is 3 incheslong, 1 inch wide, and 0.5 inches deep. The top and bottom of the case300 are 0.05 inches thick, while the sides of the case 300 are 0.075inches thick. The case may be manufactured from any number of materials,such as plastic, metal, wood, composites, and/or any other suitablematerial. The case 300 shown in FIGS. 3A and 3B, for example, ismanufactured from hard plastic.

The case 300 includes a power connection 320 for powering theinterchange device 200 and/or for recharging an energy storage devicesuch as a battery. The case 300 also includes an interface module 310with four separate ports to accommodate different wired connections tothe adapter 240, including a serial port interface (SPI) port 330, aninfrared input 340, a mini-jack port 350 (i.e.—a 3.5 mm TRS connector),and a super mini-jack port 360 (i.e.—a 2.5 mm TRS connector). Theinterface module 310 may include any number and type of wired connectionports.

The interface module 310 may include any suitable portion of the medicaldata interchange device 200. In one embodiment, referring to FIG. 2B,the interface module 310 is an adapter module 240 that includes thedevice interface 242. The plurality of wired connection ports (330, 340,350, and 360) are coupled to the adapter 240, which in turn communicatesdata to the rest of the medical data interchange device 200 through thedevice interface 242. In this embodiment, the interface module 310 isremovably attached to the case 300 to allow different modules 310 to beinterchangeably connected to the case 300 to communicate with differentmedical devices 250.

In another exemplary embodiment, referring again to FIG. 2A, theinterface module 310 contains the device interface 242 that couples toan external adapter 240. In this embodiment, the adapter 240 includesone or more connections to one or more medical devices 250. Theconnections to the medical devices 250 can be through a common wiredconnection 252, such as a PCI bus, ISA bus, PCI-E bus, SPI, USB, orother common connection. The connections to the medical devices 250 mayalso be made through individual wired connections to each medical device254. The adapter 240 can communicate with any number of medical devices250 through any combination of common wired connections 252 andindividual wired connections 254.

In the exemplary embodiment depicted in FIG. 2A, the adapter 240 alsoconnects to the device interface 242, through one or more wiredconnections 256. The wired connection 256 between the adapter 240 andthe device interface 242 can be a single shared wired connection thatcommunicates data to and from every medical device 250 connected to theadapter 240. The adapter 240 can also communicate with the deviceinterface 242 through a plurality of wired connections 256, wherein eachwired connection 256 is dedicated to communicating with a separatemedical device 250. The adapter 240 can also communicate with the deviceinterface 242 through any combination of dedicated or sharedconnections.

The adapter module 310 may be removably attached to the rest of the case300 to allow different modules with different types of wired connectionports to be interchangeably used, as depicted in FIG. 2B. The adaptermodule 310 may include any of the elements of the medical datainterchange device 200, as well as any other desired systems anddevices.

In another exemplary embodiment of the present invention, referring nowto FIGS. 3C and 3D, a case 370 includes a removable adapter module 380that includes a medical device connector 385 for communicating with amedical device through a wired connection. The adapter module 380connects to the case 370 using plug 387. The plug 387 attaches to acorresponding port on the case 370 (not shown) to hold the adaptermodule 380 in place and allow the communication of data through theadapter module 380. The connector 385 and plug 387 can use any desiredwired connection, and need not use the same type of wired connection. Inone embodiment, for example, referring to FIG. 3E, a case 395 includes a2.5 mm or 3.5 mm stereo plug connector 397 connected to a USB jack onthe side of the case 395 (not shown). In this embodiment, the adaptermodule 380 is implemented in a component 398 that electrically couplesthe stereo plug connector 397 and USB jack. The component 398 includescircuitry (such as that depicted in FIGS. 6 and 7) to convert and/orredirect the signals from the stereo plug 397 to the USB jack and viceversa.

The adapter module 380 connects to the case 370 using plug 387. The plug387 attaches to a corresponding port on the case 370 (not shown) to holdthe adapter module 380 in place and allow the communication of datathrough the adapter module 380. The connector 385 and plug 387 can useany desired wired connection, and need not use the same type of wiredconnection. In the present embodiment, for example, the connector 385 isa 2.5 mm or 3.5 mm stereo jack while plug 387 is a USB plug.

The case can include any other suitable features. For example, the casemay include a screen, lights, LEDs, keys, and speaker and microphonegrilles to support features of a user interface included in a system formedical data interchange. The exemplary systems for medical datainterchange shown in FIGS. 2A, 2B, 3A, 3B, 3C, 3D, and 3E are allconfigured to fit in a container along with the medical device itcommunicates with to allow a user to easily transport the medical deviceand the data interchange device together. In the exemplary system formedical data interchange depicted in FIG. 2C, the medical datainterchange device 200 is integrated within the case or packaging of themedical device 250 itself.

Other embodiments of systems for medical data interchange according toaspects of the present invention can be configured to be in small enoughto be coupled with or integrated into a medical device 250 or anintermediary device 260. For example, a medical device 250 may bemanufactured to include a medical data interchange device 200 within thepackaging or housing of the medical device 250. Similarly, a medicaldata interchange device 200 can be integrated as part of an intermediarydevice 260 such as a cellular phone, PDA, or other mobile computingdevice. The intermediary device 260 could thus be configured to bothreceive data from a medical device 250 through a wired connection, aswell as transmit messages regarding the medical device 250 and/orpatient to a medical data server 270.

Alternatively, a medical data interchange device 200 can be configuredto be physically attached to a medical device 250 or intermediary device260. For example, where an intermediary device 260 such as a mobilewireless telephone or PDA is used in conjunction with embodiments of thepresent invention, one exemplary embodiment of a medical datainterchange device 200 and its case 300 is configured to match the sizeand shape of the of the intermediary device 260 and attach to the backof the intermediary device 260 using metal or plastic clips that wraparound the face and/or sides of the intermediary device 260. Whenattached, the medical data interchange device 200 conforms to the sizeand shape of the outline of the intermediary device 260, and ispreferably shaped to conform to the dimensions of the back of theintermediary device 260 to avoid unnecessarily impacting the originalsize of the intermediary device 260. In this embodiment, the case of themedical data interchange device 200 may also include other desirablefeatures, such as a belt clip to allow the data interchangedevice/intermediary device combination to be worn by a user.

Turning to FIG. 4, in another exemplary embodiment of the presentinvention, the medical data interchange device 200 is contained in aflexible, protective container 400 that opens to allow a medical device250 to be likewise contained therein. The container 400 could also beconfigured to hold an intermediary device 260 (such as a cellular phone,PDA, or other mobile computing device) to allow a medical datainterchange device 200 to be used with a variety of intermediary devices260, which may (in some cases) provide a more cost effective approach tointegrate the medical data interchange device 200 with an intermediarydevice 260 or medical device 250. The medical data interchange device200 can also be integrated within the protective container 400 itself,with the container 400 acting as the case for the data interchangedevice 200.

Alternatively, as depicted in FIG. 4, the medical data interchangedevice 200 may simply be contained within a pouch 410 or other structurewithin the container 400. The exemplary container 400 depicted in FIG. 4also includes a holder 420 for the medical device 250 formed from clearplastic to allow a user to read a display 422 and/or operate keys 424 onthe medical device 250. The protective container 400 can also be sizedto comfortably fit and protect any other desired item, such as a dayplanner, wallet, notepad, and/or writing utensil or PDA stylus. Theprotective container 400 can be made from any combination of desiredmaterials, such as leather, plastic, nylon, cordura, or other flexiblematerial. The protective container 400 can be sealed in any manner, suchas by using snaps, hook-and-loop closures, buttons, and/or a zipper. Theexemplary container 400 depicted in FIG. 4, for example, is sealed usinga zipper 430. The container 400 can be waterproof, heat resistant,and/or include padding to protect the medical data interchange deviceand other contents from the shock of a fall. The container 400 mayinclude any number of pockets, pouches, or other sub-containers insideor outside the case to hold accessories associated with the medicaldevice 250, intermediary device 260, or other item(s) stored within thecontainer 400.

The exemplary protective container 400 depicted in FIG. 4 is configuredto hold a medical device 250 (specifically, a glucose meter) and amedical data interchange device 200 according to an aspect of thepresent invention. In this exemplary embodiment, the protectivecontainer 400 is closed using a zipper 430 that runs along the exteriorof the sides of the container 400. A user unzips the two halves of thecontainer 400 and opens the container 400 to display the glucose metercontained in the holder 420 attached to the interior of one half of thecontainer 400, while the medical data interchange device 200 iscontained in a pouch 410 attached to the interior of the other half ofthe container 400. The pouch 410 is formed from a nylon mesh material toallow a user to see and/or interact with user interface features of themedical data interchange device 200. The pouch 410 is sealed with azipper 412. The container 400 includes a flexible elastic strap 440 tohold a container of blood sugar metering strips 442. The container 400may include any number of other pouches or containers on the interior orexterior of the container for storing batteries and/or power cables forthe glucose meter and/or medical data interchange device, and otheritems of use to the patient carrying the container, such as bottles ofinsulin and needles for use by the patient depending on the outcome of areading by the glucose meter.

Processor 210

The processor 210 retrieves and executes instructions stored in thememory 220 to control the operation of the medical data interchangedevice 200. Any number and type of processor(s) such as an integratedcircuit microprocessor, microcontroller, and/or digital signal processor(DSP), can be used in conjunction with the present invention. Referringnow to FIG. 5A, an exemplary medical data interchange device 200according to an aspect of the present invention is implemented using amicrocontroller 501. In the exemplary system depicted in FIG. 5A, themicrocontroller 501 includes a Universal AsynchronousReceiver/Transmitter (UART) and Universal Serial Bus (USB). Themicrocontroller 520 depicted in FIG. 5B also includes these features,along with a digital signal processor (DSP) for communication with acellular RF Transceiver 530 as will be discussed in more detail below.The microcontrollers 501, 520 depicted in FIGS. 5A and 5B, respectivelycan include any other suitable components and features, such ascomparators (504), analog-to-digital converters (ADCs) (517), and/ordigital-to-analog converters (DACs) (512), though these components havebeen shown outside the microcontrollers 501, 520 for clarity.

Memory 220

The exemplary systems depicted in FIGS. 2A and 2B include a memory 220.The memory 220 stores instructions, medical device data, messagestransmitted to or received from the medical data server 270, and anyother suitable information. A memory 220 operating in conjunction withthe present invention may include any combination of different memorystorage devices, such as hard drives, random access memory (RAM), readonly memory (ROM), FLASH memory, or any other type of volatile and/ornonvolatile memory.

In the exemplary embodiments depicted in FIGS. 5A and 5B, themicrocontroller 501 and 520 each include an on-chip memory. In addition,the microcontroller 501, 520 is coupled to a flash memory 510. The flashmemory 510 may be of any size to achieve any desired purpose. In thisexemplary embodiment, the size of flash memory 510 is selected toadequately store pre-recorded voice recordings to be played through thespeaker 515, discussed below. Any number of memory storage devices ofany size and configuration may also be used in conjunction with thepresent invention.

Power Source

Any number, combination, and type of suitable power sources can beutilized in accordance with aspects of the present invention. Theexemplary systems depicted in FIGS. 5A and 5B are powered by a pair ofreplaceable alkaline AAA 1.5 volt batteries 505. The positive lead ofthe series-coupled battery pair 505 is connected to ADC 517 to enablethe microcontroller 501, 520 to monitor the voltage level of thebatteries 505. Any number of other suitable batteries may also be usedaccording to any desired criteria. For example, a rechargeable batteryor batteries integrated with the data interchange device may be selectedto reduce the overall size of the medical data interchange device 200and/or provide for the convenience of a user who would not need toreplace batteries. Such rechargeable batteries can be charged throughthe USB connector 502, as well as through a dedicated power connector.Any battery of any suitable type and size may be used. Replaceablebatteries may be selected to reduce the price of the medical datainterchange device. The power supply circuitry shown in FIGS. 5A and 5Bis exemplary only, and may be implemented by using other conventionalpower supply approaches. The medical data interchange device 200 andother systems for medical data interchange according to various aspectsof the present invention can utilize any appropriate power supplydevices, components, circuits, and systems.

In the exemplary circuits shown in FIGS. 5A and 5B, voltage from thebatteries 505 is supplied to two DC to DC converters 506, 507 whichsupply an appropriate voltage level to the various components of themedical data interchange device 200. DC converter 506 steps up thevoltage to 5 volts, while DC converter 507 steps up the voltage to 3.3volts. Any number of voltage converters or similar components may beused as desired to supply appropriate voltage levels to components ofthe medical data interchange device 200.

Data Relay Transceiver 230

The data relay transceiver 230 communicates with one or moreintermediary devices 260, medical data servers 270, or other suitablesystems. Any suitable communications device, component, system, andmethod may be used in conjunction with the present invention. In theexemplary circuits shown in FIGS. 5A and 5B, the data relay transceiver230 comprises a Bluetooth transceiver 509 that is in bidirectionalcommunication with microcontroller 501, 520 through multiplexer 508. Themultiplexer 508 allows the microcontroller 501, 520 to alternatelycommunicate with the USB port 502 and the Bluetooth transceiver 509through a single UART on the microcontroller 501, 520.

The medical data interchange device 200 may include, or operate inconjunction with, any number of data relay transceivers 230. In FIG. 5B,for example the exemplary medical data interchange device 200 furtherincludes a cellular radio frequency (RF) transceiver 530 incommunication with microcontroller 520. In this exemplary embodiment,the microcontroller 520 is a cellular baseband processor that includes adigital signal processor (DSP) which communicates data through acellular RF power amplifier and front end 540 connected to a cellularantenna 545. Data is transmitted by the microcontroller 520 on the CELLTX INTRF line and received by the microcontroller on the CELL RX INTRFline. Additionally, the microcontroller 520 can control various featuresof the RF transceiver 530 via the CELL CONTROL line. The RF poweramplifier and front end 540 performs the necessary functions to transmitand receive cellular signals, such as power amplification, powerdetection, filtering, and input/output matching.

The medical data interchange device 200 depicted in FIG. 5B may beconfigured to communicate using any number and type of cellularprotocols, such as General Packet Radio Service (GPRS), Global Systemfor Mobile Communications (GSM), Enhanced Data rates for GSM Evolution(EDGE), Personal Communication Service (PCS), Advanced Mobile PhoneSystem (AMPS), Code Division Multiple Access (CDMA), Wideband CDMA(W-CDMA), Time Division-Synchronous CDMA (TD-SCDMA), Universal MobileTelecommunications System (UMTS), and/or Time Division Multiple Access(TDMA). A medical data interchange device 200 operating in conjunctionwith the present invention may alternatively (or additionally) includedata relay transceiver 230 components to communicate using any othermethod of wired or wireless communication.

As discussed previously, the medical data interchange device 200 cantransmit any data to any entity operating in conjunction with thepresent invention. For example, the medical data interchange devices 200depicted in FIGS. 5A and 5B may transmit medical data to one or moreintermediary devices 260, as well as to one or more medical data servers270.

Adapter Module 240

Referring again to FIG. 2A, the exemplary medical data interchangedevice 200 includes an adapter module 240 for communicating with one ormore medical devices 250 as well as other suitable systems. The adaptermodule 240 can be configured to communicate with any suitable class,type, and/or manufacturer of medical device 250. The adapter module 240depicted in FIG. 2A is an external component that communicates with adevice interface 242 in the medical data interchange device 200. In theexemplary circuits depicted in FIGS. 5A and 5B, the USB port 502 isconfigured to interface with a standard USB connection, as well as withthe adapter interfaces 601 and 701 (shown on FIGS. 6 and 7,respectively) which utilize USB connectors, but not the USBcommunications protocol. Instead, the adapters depicted in FIGS. 6 and 7implement a customized protocol tailored to communicating with medicaldevices 250 through ring/tip connectors 605 and 705. The microcontroller501, 520 is configured to detect and utilize the same communicationsprotocol as an adapter module 240 connected to port 502.

In accordance with various aspects of the present invention, the adaptermodule 240 can also be modular and removably attached to the body of thedata interchange device 200, integrated as part of the data interchangedevice 200, or a combination of the two. In the exemplary embodiment ofthe present invention depicted in FIG. 2B, an adapter module 240 isremovably attached to the body of the medical data interchange device200 and includes the device interface 242 to allow different medicaldevices 250 to interoperate with the data interchange device 200. As newmedical devices 250 and/or new wired connections are utilized, a modularadapter module 240 configured to communicate with the new device or newfrequency can be added to the existing system.

Software running on or operating in conjunction with the adapter module240 can be configured/updated through the device interface 242,auxiliary communication system 244, the user interface 290, or inresponse to a communication from an intermediary device 260 or medicaldata server 270 received through the data relay transceiver 230. Thisallows the functionality of the medical data interchange device 200 tobe dynamically updated and avoids the expense of having to create customhardware implementations for every type of medical device to bemonitored.

FIG. 6 depicts a circuit diagram of an adapter module 240 thatinterfaces with the data interchange device 200 through a USB connector601. As stated previously, the adapter 240 adjusts the voltage levels ofTx and Rx in order to communicate with a medical device 250 connected toTRS connector 605. An adapter 240 operating in conjunction with thepresent invention may use any combination of wired connections andcommunication protocols.

The adapter module 240 depicted in FIG. 6 is configured to interfacewith a medical device 250 that sends a wakeup signal. In operation, asignal received from the medical device 250 on the Rx line is providedto the USB connector 601 through a buffer 602 that provides isolationbetween the medical device 250 and the circuitry of the medical datainterchange device 200 depicted in FIGS. 5A and 5B. The Rx signal isalso provided to switch 607 which places a voltage on the AID pin of theUSB connector 601. Referring back to FIGS. 5A and 5B, the voltage fromthe AID pin on connector 601 is provided to the comparator 504 throughthe ID pin on the USB port 502. The comparator 504 then activates themicrocontroller 501, 520 in response. The level of voltage provided onthe AID pin can also be used to identify the type of meter and/oradapter connected to the medical data interchange device 200 to themicrocontroller 501, 520.

Referring again to FIG. 6, the Tx lead from the USB connector 601 isdriven logically high when the UART on the microcontroller 501 is idle.The Tx signal from the USB connector 601 is inverted by inverter 603.When the UART on the microcontroller is idle, the inverter 603 drivesthe signal low, turning transistor 604 off and allowing the Tx signal tothe tip of connector 605 to float at the voltage level from the medicaldevice 250. Alternatively, when the UART on the microcontroller 501 isactive, the Tx signal from the USB connector 601 is logically low andthe inverter 603 inverts the low signal high to activate transistor 604and allow the Tx signal from connector 601 to drive the Tx line on theTRS connector 605 to the medical device 250.

FIG. 7 depicts a circuit diagram for another adapter 240 according tovarious aspects of the present invention. In this exemplary embodiment,USB connector 701 interfaces with USB port 502 shown in FIGS. 5A and 5B.Inverter 702 inverts the logic level of the Tx signal provided by themicrocontroller 501 through the USB connector 701 to correspond to thevoltage levels used by a medical device 250 connected to TRS connector705. The Rx signal from a medical device 250 connected to the TRSconnector 705 is provided to an N-channel JFET 704. In this exemplarycircuit, when the Rx signal from the medical device 250 is marking (a−5.5 volt signal indicative of a logical “1”) the JFET 704 is turnedoff, causing a 5-volt signal to be provided through buffer 703 and tothe Rx lead of the UART on the microcontroller 501. Alternatively, whenthe Rx signal from the medical device 250 is spacing (a 6-volt signalindicative of a logical “0”) the JFET 704 is turned on, causing groundto be provided through buffer 703 and to the Rx lead of the UART on themicrocontroller 501, 520. The present invention can be configured tooperate in conjunction with any other combination of voltages betweenthe microcontroller 501, 520 and the TRS connector 705.

Device Interface 242

The device interface 242 communicates with one or more medical devices250. The device interface 242 can also communicate with any othersystem, device or entity. The device interface 242 may include anynumber and combination of hardware and/or software components. Thedevice interface 242 can communicate with medical devices through anadapter 240, as shown in FIG. 2A. In this exemplary embodiment, thedevice interface 242 connects to an external adapter 240 configured tocouple with one or more medical devices 250. In this way, adapters 240that allow connections to different medical devices can be usedinterchangeably with the same medical data interchange device 200. Inanother exemplary embodiment, referring to FIG. 2B, the device interface242 is integrated with the adapter 240.

Any number of adapter modules 240 may be used in conjunction with thepresent invention, for example to communicate with multiple medicaldevices 250 using different wired connections and/or communicationprotocols. The present invention may be used in conjunction with anywired connection and communication protocol to communicate with one ormore medical devices. For example, the medical data interchange device200 may be configured to communicate with one or more medical devicesusing, without limitation: tip and sleeve (TS), tip, ring, and sleeve(TRS), and tip, ring, ring, and sleeve (TRRS) connections; serialperipheral interface bus (SPI) connections; universal serial bus (USB)connections; RS-232 serial connections, Ethernet connections, opticalfiber connections, and Firewire connections.

In the exemplary embodiments depicted in FIGS. 2A and 2B, the deviceinterface 242 and/or adapter 240 can be configured (e.g. through asoftware program residing in memory 220 and executed by processor 210)to detect and switch to different communication protocols and/ordifferent wired connections to one or more medical devices 250 or otherdevices (such as the computer system 280), thus providinginteroperability between types and manufacturers of a wide variety ofdevices. The auxiliary communication system 244 depicted in FIG. 2B maysimilarly be configured.

The medical data interchange device 200 can be configured toautomatically request data from one or more medical devices 250 atpredetermined times using the device interface 242. Any appropriate dateor time setting may be used. The data interchange device 200, medicaldevice 250, or any other device operating in conjunction with thepresent invention can be configured to automatically request and/ortransmit data in any suitable manner. For example, the medical datainterchange devices 200 depicted in FIGS. 2A and 2B can be configuredthrough the device interface 242, the user interface 290, and/or from acommand issued transmitted by an intermediary device 260 through thedata relay transceiver 230. Additionally the medical data interchangedevice depicted in FIG. 2B can be configured through the auxiliarycommunication system 244. In the case of a command received through thedata relay transceiver 230, the command can be generated by any suitableentity, such as from a medical data server 260 or a user of theintermediary device.

The automatic requesting/transmission of data by a device operating inconjunction with the present invention may be subject to any suitableconditions or rules that dictate whether the data is in factrequested/transmitted. For example, a medical data interchange device200 programmed to request data from a medical device 250 at a set timemay first check to verify that the medical device is within range, thatthe translator 200 has sufficient battery reserves to send the requestand receive the data, whether the translator 200 has sufficient space inthe memory 220 to store the data, and/or whether any other suitablecondition is met.

Auxiliary Communication System 244

The medical data interchange device 200 depicted in FIG. 2B includes anauxiliary communication system 244 for communicating with additionalsystems and devices. For example, the auxiliary communication system 244may be used to communicate with an external personal computer system 280to upload software to the data interchange device 200, store data,provide or update encryption keys, perform diagnostics, and otherappropriate purposes. The auxiliary communication system 244 can be aseparate device, system, and/or component, or may be integrated withanother component, such as the device interface 242. For example, in oneembodiment of the present invention, the device interface 242 includes aUSB port for communicating with any device capable of communicatingthrough a USB connection. This allows the medical data interchangedevice 200 to communicate instructions, software upgrades, medical data,and other information with computing devices, memory storage devices(such as portable USB memory drives), as well as medical devices. Thesame device interface 242 can thus be used to receive medical data froma medical device 250 as well as to download reports that include themedical data. In one embodiment, medical data received by the medicaldata interchange device 200 may be formatted by the processor 210 into aubiquitous data format such as Portable Document Format (PDF), andsubsequently transferred to an external device such as a computer system280 through the auxiliary communication system 244.

The medical data interchange device 200 or other system operating inconjunction with the present invention can include any suitable circuit,component, device, and system for communicating with any other device.The auxiliary communication system 244 can be used to transfer data toand from the medical data interchange device 200, as well as for anexternal computer system 280 to configure or program software andhardware in the data interchange device 200. In one embodiment of thepresent invention, for example, a user operating computer system 280connected to medical data interchange device 200 through the Internetcan configure settings for the device interface 242, adapter 240, datarelay transceiver 230, and user interface 290. The computer system 280can also download data received by the data interchange device 200 fromone or more medical devices 250. Additionally, the computer system 280may communicate with the medical devices 250 real-time through themedical device transceiver 240, such as to monitor or control one ormore medical devices 250 in real-time.

User Interface 290

The medical device 250, medical data interchange device 200,intermediary device 260, or other device operating in conjunction withthe present invention may include a user interface. Referring to FIGS.2A and 2B, an exemplary user interface 290 of a medical data interchangedevice 200 in accordance with aspects of the present invention includesan input device 292 and an output device 294. The input device 292receives commands, data, and other suitable input from a user. Theoutput device 294 provides the user with data, alerts, and othersuitable information from the medical data interchange device 200.

Any number of input devices may be included in a user interface for oneor more devices in the present invention. In one embodiment of thepresent invention, for example, the user interface 290 includes a touchpad, a touch screen, or an alphanumeric keypad to allow a user to enterinstructions and data into the medical data interchange device 200. Oneor more buttons on the keypad or touch screen can be programmed orconfigured to perform specific functions, such as to request data fromone or more medical devices. The user interface 290 can also include oneor more multifunction switches, keys, or buttons that each allows a userto perform multiple functions.

The user interface may also include a microphone to allow the user toprovide such information to the medical data interchange device 200verbally. In this exemplary embodiment, the medical data interchangedevice 200 also includes speech recognition software to process verbalinput through the user interface 290. The ability of the medical datainterchange device to recognize speech from a patient can beparticularly useful for users/patients who have vision problems,arthritis, or other impairments that would inhibit them from using akeypad or other input device. A microphone can be used in conjunctionwith audible (e.g. through sound waves perceivable by the human ear)data provided through a speaker, as discussed below, to allow a user tointeract with any device operating in conjunction with the presentinvention in a completely auditory manner. In one nonlimiting example,audible input could also be sensed and analyzed by the medical datainterchange device 200 that a patient has uttered a command, such as thecommand to turn on. Bidirectional audible communication, in addition toaiding impaired patients, allows users to operate devices in the presentinvention in a hands-free manner which can increase the speed, ease, andefficiency in which a device (such as the medical data interchangedevice 200) can be utilized.

Devices operating in conjunction with the present invention may includeany number of suitable output devices. Referring to the exemplarymedical data interchange device circuits depicted in FIGS. 5A and 5B, auser interface 290 including two lights 511 (LED1 and LED2) may be usedto indicate the status of the medical data interchange device 200 to theuser, as well as other pertinent information. For example, a flashingLED can be used to indicate when data from a medical device is in theprocess of being transferred, while a solid LED can indicate thetransfer of data is complete. The medical data interchange devices 200depicted in FIGS. 5A and 5B also provide auditory output through speaker515. The microcontroller 501, 520 retrieves audio samples, such asrecorded speech, from the EEPROM 510 and provides output to DAC 512,which converts the digital signal from the microcontroller 501, 520 toan analog signal that can be output on the speaker 515. The analogsignal is provided to an audio amplifier 514 that amplifies the signal.The gain of the amplifier 514 is set by the ratio of resistors 516 and513.

Any other suitable user interface features may similarly be included indevices and systems operating in accordance with the present invention.In another exemplary embodiment, for example, the output device 294includes a display screen to visually display information as well as aspeaker (e.g. speaker 515 shown in FIGS. 5A and 5B) to provide auditoryoutput. The output device 294 can include multiple transducers such asaudio speakers or piezoelectric elements, amplifiers, and otherappropriate devices and systems to provide the auditory output. Themedical data interchange device 200 may be configured to provide words,phrases, tones, recorded music, or any other type of auditory output toa user.

Any type of information may be communicated through the user interface290, such as the biological, biometric, or behavioral information forone or more patients. The user interface can provide/receive any othersuitable information, such as environmental information and/ordiagnostic data for a medical device, a battery charge level, atemperature, a barometric pressure, a code relating to an accessory forthe medical device, a biometric access measurement, a data validitymeasurement, an elapsed time since a previous reading by the medicaldevice, a test result parameter, a signal-to-noise parameter, and aquality of service (QoS), and combinations thereof.

Information provided or received by the user interface 290 may be in anyappropriate format. For example, a user interface that communicatesinformation to a user in an auditory format may first provide a dataheader followed by a data value to identify the data to the user.Similarly, an output device 294 providing information to a user visuallymay provide a series of measurements in the form of a spreadsheet withheaders indicating the source of the measurements. The output device 294can also provide information in any number of desired languages,regardless of whether the information is provided audibly or visually.

Various features of the user interface can be implemented in hardware,software, or a combination of the two. In the medical data interchangedevices 200 depicted in FIGS. 2A and 2B, for example, the user interface290 includes voice interface software stored in the memory 220,including tables of recorded words and phrases. When executed by theprocessor 210, the voice interface software plays the appropriaterecorded words and phrases (such as enunciating the medical data)through a speaker such as one included in the output device 294 toprovide information to the user. The voice interface software, like anysoftware operating on the medical data interchange device 200, can bedownloaded and configured through the auxiliary communication system 244or device interface 242. As discussed previously, any software programon any device operating in accordance with the present invention can beprogrammed or configured through any other suitable interface. In themedical data interchange device 200, for example, the voice interfacesoftware could also be downloaded and configured through the data relaytransceiver 230 in response from a command from a medical data server270 and/or intermediary device 260, as well as from input from the userthrough the user interface 290. Accordingly, the voice interfacesoftware can be configured to include words and phrases in any number ofdifferent languages, and can be updated with new words and phrases asdesired, such as to accommodate a new medical device 250 operating withthe medical data interchange device 200. Non-verbal sounds, such asmelodies and tones, can also be stored and used by the user interface294 to provide alerts, indicators, and other information to the user.

The user interface can also provide/receive information to a user in amachine-readable format. In one exemplary embodiment of the presentinvention, for example, the user interface 290 of a medical datainterchange device 200 includes a fixed or retractable USB port tocommunicate with a thumb drive, memory stick, portable hard drive, anexternal computer system, or other USB-compatible device. This allowsdoctors and other healthcare providers to directly access the medicaldata interchange device 200 directly, without having to retrieve thedata from a medical data server. In this exemplary embodiment, themedical data interchange device 200 can be configured to send, receive,and process machine-readable data can in any standard format (such as aMS Word document, Adobe PDF file, ASCII text file, JPEG, or otherstandard format) as well as any proprietary format. Machine-readabledata to or from the user interface may also be encrypted to protect thedata from unintended recipients and/or improper use. In an alternateembodiment, a user must enter a passcode to enable use of the USB port,and optionally, after a period of time of non-use, the USB port isautomatically disabled. Any other user interface feature may be utilizedto allow a human or non-human user to interact with one or more devicesoperating in conjunction with the present invention.

Power Saving Features

A medical data interchange device, intermediary device, medical device,or other system operating in accordance with aspects of the presentinvention may include any other suitable features, components, and/orsystems. For example, the data interchange device 200 or other devicemay be configured to preserve the life of its battery by shutting off orgoing into a low-power mode when it, and/or the medical device itmonitors, experiences a predetermined period of non-use, or a change ina measured parameter such as indication that a case holding thetranslator 200 has been actuated to a closed position. Such devices canalso be configured to become active in response to any suitable event,such as receiving a signal from a device (such as a sensor).

In one non-limiting embodiment of the present invention, referring nowto FIG. 8, a medical data interchange device 200 communicates with amotion sensor 810 and a light sensor 820 to determine when a container830 holding the data interchange device 200 and the medical device 250it monitors is open or closed. In this exemplary embodiment, the datainterchange device 200 can preserve the life of its battery by shuttingoff or going into a low-power mode when the container 830 is closed and,therefore, the medical device 250 held in the container 830, is not inuse. Any type of motion sensor can be used in accordance with thepresent invention, such as an accelerometer, tilt switch, or otherdevice that generates a signal in response to movement. Similarly, anytype of light sensor may be used in conjunction with the presentinvention. The light sensor can be used to detect the amount of lightentering a container 830 holding the medical device, medical datainterchange device, or other device to activate the device when thesensed amount of light exceeds a predetermined threshold, or if anincrease in the amount of incident light exceeds a predeterminedthreshold. In an alternate embodiment, a microphone may receive audiblesignals that are analyzed by the medical data interchange device 200 toindicate a command has been uttered that indicates that the medical datainterchange device 200 should be shut down or activated from a quiescentor low-power state.

A sensor may be integrated into the medical data interchange device 200,or operate externally to the data interchange device 200, communicatingwith the data interchange device 200 wirelessly or through a wiredconnection. For example, in the exemplary embodiment depicted in FIG. 8,the motion sensor 810 and light sensor 820 are integrated into theinterior of the container 830 and communicate with a medical datainterchange device 200 contained within to indicate when the container830 is actuated from a closed position to an open position.

Security Measures

Systems and devices operating in accordance with aspects of the presentinvention may implement one or more security measures to protect data,restrict access, or provide any other desired security feature. Forexample, any device operating in conjunction with the present inventionmay encrypt transmitted data and/or protect data stored within thedevice itself. Such security measures may be implemented using hardware,software, or a combination thereof. Any method of data encryption orprotection may be utilized in conjunction with the present invention,such as public/private keyed encryption systems, data scramblingmethods, hardware and software firewalls, tamper-resistant ortamper-responsive memory storage devices or any other method ortechnique for protecting data. Similarly, passwords, biometrics, accesscards or other hardware, or any other system, device, and/or method maybe employed to restrict access to any device operating in conjunctionwith the present invention.

The particular implementations shown and described above areillustrative of the invention and its best mode and are not intended tootherwise limit the scope of the present invention in any way. Indeed,for the sake of brevity, conventional data storage, data transmission,and other functional aspects of the systems may not be described indetail. Methods illustrated in the various figures may include more,fewer, or other steps. Additionally, steps may be performed in anysuitable order without departing from the scope of the invention.Furthermore, the connecting lines shown in the various figures areintended to represent exemplary functional relationships and/or physicalcouplings between the various elements. Many alternative or additionalfunctional relationships or physical connections may be present in apractical system.

Changes and modifications may be made to the disclosed embodimentswithout departing from the scope of the present invention. These andother changes or modifications are intended to be included within thescope of the present invention, as expressed in the following claims.

1. A method comprising: receiving data from a medical device through oneor more of: a wired connection; and a wireless connection; formatting amessage including the received data for transmission to one or more of:a medical data server; and a intermediary device, wherein theintermediary device includes a software program configured to retransmitthe message to the medical data server.
 2. The method of claim 1,wherein the data is received from the medical device through a wiredconnection selected from the group consisting of an optical fiberconnection, a tip and sleeve (TS) connection, a tip, ring, and sleeve(TRS) connection, a tip, ring, ring, and sleeve (TRRS) connection, aserial peripheral interface bus (SPI) connection, a universal serial bus(USB) connection, an RS-232 serial connection, an Ethernet connection, aFireWire connection, and combinations thereof.
 3. The method of claim 1,wherein the data is received from the medical device through a wirelessconnection using a protocol selected from the group consisting of aZigbee protocol, a Wibree protocol, an IEEE 802.11 protocol, an IEEE802.15 protocol, an IEEE 802.16 protocol, an Ultra-Wideband (UWB)protocol, an Infrared Data Association (IrDA) protocol, a Bluetoothprotocol, and combinations thereof.
 4. The method of claim 1, whereinthe data includes respective information regarding one or more patientsassociated with the medical device.
 5. The method of claim 4, whereinthe respective information regarding the one or more patients associatedwith the medical device includes a patient identifier for each of therespective one or more patients.
 6. The method of claim 4, furthercomprising analyzing the information for the one or more patients toidentify a respective condition for the one or more patients.
 7. Themethod of claim 6, further comprising contacting a patient from the oneor more patients when the information and the condition for the patientsatisfies respective predetermined thresholds.
 8. The method of claim 4,further comprising contacting a patient from the one or more patientswhen information from the patient is not received for a predeterminedinterval.
 9. The method of claim 1, wherein the data includes anenvironmental parameter, wherein the environmental parameter includes atleast one of a battery charge level, a temperature, a barometricpressure, a code relating to an accessory for the medical device, a datavalidity measurement, an elapsed time since a previous reading by themedical device, a test result parameter, a signal-to-noise parameter,and a quality of service (QoS) parameter.
 10. The method of claim 1,further comprising authenticating one or more of: the intermediarydevice; and the medical data server.
 11. The method of claim 1, whereinthe formatted message is transmitted through a wireless network selectedfrom the group consisting of: a cellular network; a General Packet RadioService (GPRS) network; a wireless Local Area Network (WLAN); a GlobalSystem for Mobile Communications (GSM) network; a Personal CommunicationService (PCS) network; an Advanced Mobile Phone System (AMPS) network; asatellite communication network; and combinations thereof.
 12. Themethod of claim 11, wherein transmitting the formatted message includesselecting a transmission method from a plurality of transmission methodsbased at least partially on a cost associated with the transmissionmethod.
 13. The method of claim 1, wherein formatting the messageincludes processing the data into one or more formats, the one or moreformats including at least one of an XML record, an SMS text message, anemail, and a facsimile.
 14. The method of claim 1, further comprisingreceiving a command from the medical data server.
 15. The method ofclaim 14, further comprising receiving input from a user, wherein thecommand is generated in response to interpretation of the input.
 16. Themethod of claim 14, wherein the command reconfigures a softwareapplication running on the intermediary device.
 17. The method of claim14, wherein the command controls the medical device.
 18. The method ofclaim 1, further comprising requesting a medical device identifier fromthe medical device.
 19. The method of claim 18, wherein receiving datafrom the medical device further comprises determining a medical devicetype based at least partially on the medical device identifier.
 20. Themethod of claim 1, wherein the medical device is selected from the groupconsisting of: a blood glucose meter; a pacemaker; a blood pressuremonitor; an insulin pump; a pulse oximeter; a holter monitor; anelectrocardiograph; an electroencephalograph; a blood alcohol monitor;an alcohol breathalyzer; an alcohol ignition interlock; a respirationmonitor; an accelerometer; a skin galvanometer; a thermometer; a patientgeolocation device; a scale; an intravenous flow regulator; a patientheight measuring device; a biochip assay device; a monitor forbiological agents; a hazardous chemical agent monitor; an ionizingradiation sensor; a sphygmomanometer; a loop recorder; a spirometer; anevent monitor; a prothrombin time (PT) meter; an internationalnormalized ratio (INR) meter; a tremor sensor; a defibrillator; andcombinations thereof.